Catalog Number 82321 |
Device Problems
Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the apheresis platelet product.There was not a transfusion recipient or patient involved at the time of the residual white bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.(b)(6).The platelet collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to a alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Manufacturer Narrative
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This report is being filed to provide additional information and corrected information.Investigation: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.The run data file (rdf) was analyzed for this event.Root cause: a definitive root cause for the observed elevated wbc count remains undetermined at this time.Rdf analysis did not show a conclusive root cause for the reported higher than expected wbc count for this collection.However, signals indicate that more cells than expected were going by the detector which may have contributed to the leukoreduction system chamber saturation detected late in the run.It is possible, though not conclusive, this elevated wbc count may be donor related.
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Manufacturer Narrative
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This report is being filed to provide additional information in additional mfr narrative.Additional investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Signals in the rdf confirmed that the trima machine operated as intended by flagging the procedure to verify white blood cells.
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Search Alerts/Recalls
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